FDA wants all ranitidine products off the market
The Food and Drug Administration is requesting that all prescription and over-the-counter ranitidine (Zantac) products be pulled from the market. The product is part of an ongoing investigation because it contains N-Nitrosodimethylamine (NDMA), a probable human carcinogen.
The impurity in some ranitidine products increases over time and when stored at higher than room temperature, according to an FDA safety alert. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines, and treatment of gastroesophageal reflux disease.
Before stopping prescription ranitidine, the FDA urges people to contact their health care provider for an alternative. NDMA has not been found in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec), according to the FDA.
Because of thecoronavirus disease 2019 pandemic, the FDA recommends disposing medications at home instead of returning them to a drug take-back location. Follow steps in the medication guide or package insert. If no disposal instructions are available, mix the medication with dirt, cat litter or used coffee grounds, place it in a sealed plastic bag or other container, and throw the container in the trash. Be sure to delete all personal information on the prescription label of empty medication bottles or packaging before recycling or throwing away the empty bottle or packaging.
Report adverse events or side effects related to the use of these products to the FDA MedWatch Safety Information and Adverse Event Reporting Program at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm. Read the safety alert at https://bit.ly/2URIIrs.
